Full thickness resection device control handle

ABSTRACT

A control mechanism for a resectioning device, comprises a first actuator coupled to a flexible drive shaft for actuating a first mechanism when operated in a first direction and for actuating, when operated in a second direction, a second mechanism and a first lockout mechanism coupled to the first actuator for preventing actuation of the first actuator in the second direction before a predetermined amount of actuation in the first direction has been completed. Furthermore, mechanisms are provided to control the release during operation in a second direction of torsional energy stored in a flexible drive shaft during operation in a first direction.

[0001] This application is a continuation-in-part application of U.S.patent application Ser. No. 09/722,026, filed Nov. 27, 2000.

FIELD OF THE INVENTION

[0002] The present invention relates generally to a full thicknessresection device. More specifically, the invention provides a device andmethod for controlling a full thickness resection device.

BACKGROUND INFORMATION

[0003] Known resection devices have been employed to staple and cuttissue surrounding a lesion site to remove lesions from patients'bodies. A known resection device for performing resection proceduresendoscopically through naturally occurring body orifices has included aflexible portion extending from an operating end, or distal end, of thedevice, which is inserted into the patient's body, to a control end, orproximal end, of the device, which remains outside of the patient'sbody. The control end may include a control handle which may bemanipulated to control cutting and stapling apparatuses of the device.

[0004] In order to maintain flexibility of that portion of the deviceextending between the control handle and the distal end, these resectiondevices have employed flexible drive shafts to transmit an actuatingforce from the control handle to the distal end of the device. However,as such a flexible drive shaft is rotated in the first direction tooperate the stapling mechanism, torsional energy is stored therein. Whenthe force driving the drive shaft in the first direction is removed, thestored torsional energy may urge the drive shaft to rotate in the seconddirection, actuating the cutting mechanism, before such a rotation isdesired.

SUMMARY OF THE INVENTION

[0005] The present invention is directed to a control mechanism for aresectioning device, comprises a first actuator coupled to a flexibledrive shaft for actuating a first mechanism when operated in a firstdirection and for actuating, when operated in a second direction, asecond mechanism and a first lockout mechanism coupled to the firstactuator for preventing actuation of the first actuator in the seconddirection before a predetermined amount of actuation in the firstdirection has been completed. Furthermore, mechanisms are provided tocontrol the release during operation in a second direction of torsionalenergy stored in a flexible drive shaft during operation in a firstdirection and to prevent mistaken operation of resectioning mechanismsby locking out a first actuator whenever a second actuator is operable.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The various features of the invention will best be appreciated bysimultaneous reference to the description which follows and theaccompanying drawings, in which:

[0007]FIG. 1 is an exploded perspective view of a first embodiment of afull thickness resection device control handle in accordance with thepresent invention;

[0008]FIG. 2 is an exploded perspective view of a portion of the controlhandle of FIG. 1;

[0009]FIG. 3 is a cross-sectional view of the embodiment of FIG. 2;

[0010]FIG. 4 is an exploded perspective view of a portion of the controlhandle of FIG. 1;

[0011]FIG. 5 is a perspective view of the portion of the control handleof FIG. 4;

[0012]FIG. 6 is an exploded perspective view of a portion of the controlhandle of FIG. 1;

[0013]FIG. 7 is a perspective view of the portion of the control handleof FIG. 6;

[0014]FIG. 8 is an exploded perspective view of a portion of the controlhandle of FIG. 1;

[0015]FIG. 9 is a perspective view of the portion of the control handleof FIG. 8;

[0016]FIG. 10 is an exploded perspective view of a portion of thecontrol handle of FIG. 1;

[0017]FIG. 11 is a first schematic illustration of the worm gearassembly of the embodiment of FIG. 1, as viewed from a top of theassembly;

[0018]FIG. 12 is a second schematic illustration of the worm gearassembly of the embodiment of FIG. 1, as viewed from a front of theassembly;

[0019]FIG. 13 is a cross-sectional view of the ratchet assembly of theembodiment of FIG. 1;

[0020]FIG. 14 is a cross-sectional view of a second embodiment of a fullthickness resection device control handle in accordance with the presentinvention;

[0021]FIG. 15 is an exploded perspective view of a portion of thecontrol handle of FIG. 14;

[0022]FIG. 16 is a partially exploded perspective view of the portion ofthe control handle of FIG. 14;

[0023]FIG. 17 is a cross sectional view of a third embodiment of a fullthickness resection device control handle in accordance with the presentinvention;

[0024]FIG. 18 is an exploded perspective view of a portion of thecontrol handle of FIG. 17;

[0025]FIG. 19 is a cross-sectional view of a portion of the controlhandle of FIG. 18;

[0026]FIG. 20 is an exploded perspective view of a portion of a fourthembodiment of a full thickness resection device control handle inaccordance with the present invention;

[0027]FIG. 21 is a perspective view of the portion of the control handleof FIG. 20;

[0028]FIG. 22 is an exploded perspective view of a fifth embodiment of afull thickness resection device control handle in accordance with thepresent invention;

[0029]FIG. 23 is an exploded perspective view of a portion of thecontrol handle of FIG. 22; and

[0030]FIG. 24 is an exploded perspective view of the portion of thecontrol handle of FIG. 23.

DETAILED DESCRIPTION OF INVENTION

[0031]FIGS. 1 through 13 illustrate a first embodiment for thecomponents of control handle 101 of the present invention. As can beseen, control handle 101 includes body 120, clamping or gap adjustassembly 140, resectioning assembly 160, and locking assembly 190. Eachof these components will be discussed in further detail below.

[0032] Control handle 101 is disposed at a proximal end of a fullthickness resection device (i.e., an end of the device which, duringoperation, remains, outside the body of a patient). Flexible tube 102extends from control handle 101 to a distal end of the full thicknessresection device which includes the cutting and stapling apparatuses andwhich is inserted into the body of a patient. The construction andoperation of a full thickness resectioning device is described in moredetail in U.S. application Ser. No. 09/100,393 which is expresslyincorporated herein by reference in its entirety.

[0033] As will be further described later in this specification, a gapadjust assembly 140 activates mechanisms for adjusting the size of a gapbetween a staple head and anvil head of the stapling apparatus in thedistal end of the device. Resectioning assembly 160 actuates both thestapling apparatus and a cutting apparatus which is also located at thedistal end of the full thickness resection device.

[0034] As mentioned above, control handle 101 includes a body 120including a first handle half 121 and a second handle half 122. As canbe seen in FIG. 1, the internal structure of body 120 may preferablyinclude molded support framing 119 which supports the componentsdisposed therewithin. The first handle half 121 is joined to the secondhandle half 122 with the components included within the body 120disposed therebetween. A circular handle clamp ring 123 is mountedaround proximal ends of the first and second handle halves 121 and 122,respectively, and assists in maintaining the joined configuration forthe first and second handle halves 121 and 122, respectively. Similarly,nose ring 124 is disposed around the distal ends of first and secondhandle halves 121, 122, respectively, and also assists in maintainingthe joined configuration for the first and second handle halves, 121 and122, respectively.

[0035] Scope seal 125 is disposed within body 120 and is maintained inits position therewithin by support framing 119 with scope seal 125defining an aperture 117 therethrough. When in an operativeconfiguration, an endoscope (not shown) extends through the controlhandle 101 as will be described below passing through the aperture 117,to pass through a flexible tube 102 to the distal end of the fullthickness resection device. A distal end of the scope seal 125 forms atube that extends through a portion of the flexible tube 102. Thus, inthe operative configuration, an endoscope extends through the tube ofthe scope seal 125 into the flexible tube 102. The purpose of the scopeseal 125 is to provide a seal around the endoscope such that if, forexample, an organ into which the full thickness resectioning device isinserted is insuflated, the increased air pressure is sealed within thetube 102 and prevented from escaping through the control handle 101.

[0036] Also included in body 120 are first and second grasper tubes 126and 128, each of which provides a lumen through which a separate devices(e.g., a grasper device or schlerotherapy needle) may be inserted intothe tube 102. The first grasper tube 126 extends through an opening 115in the first handle half 121 while the second grasper tube 128 extendsthrough a second opening 115 in the second handle half 122. A firstgrasper seal 127 is positioned around the first grasper tube 126 outsideof the first handle half 121 to seal the corresponding opening 115 whilea second grasper seal 129 is similarly positioned around the secondgrasper tube 128 outside the second handle half 122 to seal thecorresponding opening 115. The grasper seals 127, 129 provide a closefit around the device inserted through the respective grasper tube 126,128 to prevent materials from passing out of the proximal ends thereof.

[0037] A description will now be provided of gap adjust assembly 140. Asdescribed above, gap adjust assembly 140 allows a user to adjust thesize of a gap between a staple head and an anvil head of a staplingdevice located at the distal end of the full thickness resection device.The gap may be adjusted, for example, to clamp a portion of tissue to bestapled there before actuating the stapling device. The gap adjustassembly 140 includes a gap adjust ring 141 which may, for example beformed as a knob, a clamp shaft gear 144, a spur gear 148, a gap adjustflexible drive shaft 151, a transition piece 153, and a follower 155.Each of these components will be described in further detail below.

[0038] The gap adjust ring 141 is a circular structure having anaperture extending therethrough through which, as discussed previously,an endoscope may be inserted into the control handle 101. The gap adjustring 141 is rotatably mounted on the body 120 and includes gear teeth142 on an inner portion thereof. As will be further described, gearteeth 142 engage gear teeth 145 formed on the clamp shaft gear 144. Thegap adjust ring 141 also includes cog teeth 143 formed on an innerportion thereof. As will also be described later in this specification,cog teeth 143 which mesh with a corresponding structure of a lockingassembly 190 to prevent the gap adjust ring 141 from being rotated whenthe locking assembly 190 is received therewithin.

[0039] As shown more clearly in FIGS. 1-3, gear teeth 145 of clamp shaftgear 144 engage gear teeth 142 of gap adjust ring 141 so that, as gapadjust ring 141 is rotated, the gear teeth 142 rotate clamp shaft gear144. The clamp shaft gear 144 also defines an aperture 147 therethroughthrough which an endoscope may be inserted. Clamp shaft gear 144 alsoengages spur gear 148 as gear teeth 145 mesh with gear teeth 149 of spurgear 148. Thus, as gap adjust ring 141 rotates clamp shaft gear 144,clamp shaft gear 144 in-turn rotates spur gear 148. Spur gear 148 is notdirectly driven by gap adjust ring 141. Rather, spur gear 148 isindirectly driven by gap adjust ring 141 through rotation of clamp shaftgear 144 by gap adjust ring 141. This gearing mechanism for gap adjustassembly 140 permits the positioning of the endoscope through acenterline of the control handle 101 by offsetting the spur gear 148 andallows a designer to select a desired drive ratio for gap adjust ring141.

[0040] A shaft 150 is coupled to the spur gear 148 and extends throughand is supported by an opening 154 defined by a transition piece 153 sothat the spur gear 148 may rotate within the opening 154. The distal endof the shaft 150 of the spur gear 148 is connected to a proximal end ofa gap adjust flexible drive shaft 151 which extends to the distal end ofthe full thickness resectioning device. The proximal end 152 of thedrive shaft 151 is positioned within a scallop 156 which extends from afollower 155. Scallop 156 allows for rotation of the drive shaft 151while supporting the proximal end thereof. As the spur gear 148 isrotated by the clamp shaft gear 144, the drive shaft 151 is also rotateddue to a torsionally rigid attachment between the drive shaft 151 andthe spur gear 148.

[0041] The gap adjust drive shaft 151 is preferably formed as alongitudinally flexible, substantially torsionally rigid shaft. However,in practice such a flexible drive shaft will store torsional energytherewithin it as it is rotated. Rotation of drive shaft 151translationally moves the at least one of the anvil and stapling headswith respect to the other to adjust the stapling gap therebetween.

[0042] The follower 155 which is movably disposed on clamp shaft gear144 includes an internal threaded portion that engages a threaded shaft146 included on the clamp shaft gear 144. Thus, for example, as clampshaft gear 144 is rotated clockwise (when viewed from the proximal endof the control handle 101), the follower 155 moves proximally on clampshaft gear 144. Conversely, as the clamp shaft gear 144 is rotatedcounter-clockwise, the follower 155 will move distally on clamp shaftgear 144. As shown in FIGS. 2-4, the proximal and distal motion of thefollower 155 on clamp shaft gear 144 is limited by stops 130, 131 formedby body 120. Thus, the position of stops 130, 131 and that of thefollower 155 are preferably selected prevent adjustment of the staplinggap outside a desired range. That is, over-rotation of gap adjust ring141 in either direction is prevented and no rotation may be imparted tothe gap adjust drive shaft 151 beyond the desired limits. As would beunderstood by those of skill in the art, after the gap adjust ring 141has been rotated to either completely extend the gap between the anvilhead and staple firing head to a maximum desired distance or to reducethe gap to a minimum desired distance, the torsional energy which mayhave been stored within the gap adjust drive shaft 151 may be release sothat a further rotation is imparted to a distal end thereof. Thus, thisadditional rotation due to stored torsional energy should preferably betaken into account when setting the position of the stops 130 and 131.

[0043] As discussed previously, control handle 101 also includes aresectioning assembly 160 which is utilized to fire staples from thestapling head at the distal end of the full thickness resection device.Resectioning assembly 160 includes a resection activating mechanism 161which may be, for example, a staple firing ring or staple-cut ring, acontrolling device 162, a flexible drive shaft 163, and a staple-cuttinglockout mechanism 180 which may be, for example, a ratchet assembly asshown in FIG. 1. The resection activating mechanism 161 is coupled toand drives the flexible drive shaft 163 to drive the staple-cuttinglockout mechanism 180. The controlling device 162 engages the flexibledrive shaft 163 to control a dissipation of torsional energy built up inthe flexible drive shaft 163 during the driving of the flexible driveshaft 163 by the resection activating mechanism 161 in a first direction164. First direction 164 may be either clockwise or counterclockwise,for a first operative procedure or mode, such as tissue stapling withthe opposite direction of rotation being employed for another operation(e.g., tissue cutting). Those skilled in the art will understand thatthere are a variety of configurations available for the controllingdevice 162 which will achieve the goals of the invention. In theexemplary embodiment, the controlling device 162 is formed of a wormgear assembly 165 which couples the resection activating mechanism 161to the flexible drive shaft 163. Each of these components will bedescribed in further detail below.

[0044] The resection activating mechanism 161 is rotatably mounted onthe body 120 and includes gear teeth 166 formed on a distal, innerportion thereof. In this embodiment, the resection activating mechanism161 and the gap adjust ring 141 are concentrically aligned with respectto one another. Although the rings 141 and 161 may be positioned on body120 in a variety of ways, this concentric positioning of the rings 141and 161 on the body 120 allows an endoscope to be passed through thecenter of the control handle 101, and permits a user to utilize thecontrol handle 101 and access all the required controls regardless ofthe orientation of the control handle 101 around the endoscope.

[0045] As will be further described below, resection activatingmechanism 161 includes the gear teeth 166 which engage the worm gearassembly 165 as well as cog teeth 167 formed on a proximal, innerportion thereof. The cog teeth 167 receive therewithin the lockingassembly 190 in order to lock the resection activating mechanism 161 inposition and prevent undesired rotation thereof.

[0046] As mentioned above, and as shown in FIG. 10, the controllingdevice 162 may include a worm gear assembly 165 coupling the resectionactivating mechanism 161 to the flexible drive shaft 163. In a firstoperative mode the worm gear assembly 165 may be actuated by rotation ofthe resection activating mechanism 161 in a first 164 to rotate theflexible drive shaft 163 in the first direction 164. Furthermore, theworm gear assembly 165 may be actuated in a second operative mode, torotate in a second direction 169 when the resection activating mechanismis rotated in the second direction 169. This causes a correspondingrotation of the flexible drive shaft 163 in the second direction 169,opposite to the first direction 164. Under the second operative mode,the drive shaft 163 rotates in the second direction 169(counterclockwise) to actuate, for example, a second operative procedure(e.g., tissue cutting), by causing a corresponding action of a tissuecutting mechanism located at a distal end of the full thicknessresection device. At the beginning of the second operative mode, arelease rate of the torsional energy stored in the flexible drive shaft163, as a result of the previous rotation of the drive shaft 163 in thefirst direction 164, is controlled by actuation of the worm gearassembly 165 in the second operative mode.

[0047] Actuation of the worm gear assembly 165 in the second operativemode may be accomplished by either active rotation, i.e., rotation bythe user of the resection activating mechanism 161 in the seconddirection 169 or by simply removing a force from resection activatingmechanism 161 that restrains it from rotating in the second direction169. In other words, as the flexible drive shaft 163 has torsionalenergy stored therewithin as a result of the rotation in the firstdirection 164, it is biased to rotate in the second direction 169 unlessrestrained thereagainst, as shown in FIG. 12. When the restraining forceis removed from resection activating mechanism 161, the flexible driveshaft 163 may rotate in the second direction but will not uncontrollablyrotate due to a desirably inefficient transfer of energy resulting fromthe worm gear assembly 165, as will be further discussed.

[0048] As shown in FIGS. 1 through 4, and in more detail in FIG. 10,worm gear assembly 165 includes a worm pinion 168 and a worm gearcoupling 173. The worm pinion 168 includes a top side 170 with gearteeth 171 thereon and a stem portion 172 which includes threading alongits length. The gear teeth on the top side 170 of the worm pinion 168engage gear teeth 166 of the resection activating mechanism 161. Thus,rotation of the resection activating mechanism 161 causes acorresponding rotation of the worm pinion 168.

[0049] When the resection activating mechanism 161 is rotated in thefirst direction 164 during the first operative mode, in order to firethe staples from the stapling mechanism in the distal end of the fullthickness section device, the top side 170 of the worm pinion 168 isrotated in the second direction 169 (counter-clockwise) when viewed fromabove in FIG. 10. The rotation of the top side 170 of the worm pinion168 in the second direction 169 then rotates the threaded stem portion172 of the worm pinion 168 in the second direction 169 which engagesgear teeth 174 of the worm gear coupling 173 to rotate the worm gearcoupling 173 in the first direction 164 (clockwise when viewed from theproximal end of control handle 101).

[0050] As the flexible drive shaft 163 is attached at its proximal end175 to the worm gear coupling 173, rotation of the worm gear coupling173 by the worm pinion 168 in the first direction 164, causes theflexible drive shaft 163 to rotate in the first direction 164. Becauseof the flexibility of the flexible drive shaft 163, as discussed above,torsional energy is stored therewithin during this rotation by the wormgear coupling 173. FIG. 12 illustrates the flexible drive shaft 163after it has been rotated and with torsional energy stored therewithinas a result of the rotation.

[0051] The staple firing mechanism includes a staple-cutting lockoutmechanism that does not permit a surgeon to begin tissue cutting untilthe device has completed the tissue stapling operation (e.g., by firingstaples through an entire firing range of the stapling mechanism). Inthis embodiment, the staple-cutting lockout mechanism 180 includes aratchet assembly as shown in FIG. 10 and in more detail in FIG. 13. Thestaple-cutting lockout mechanism 180 which is associated with theflexible drive shaft 163 includes a ratchet 181, a pawl 182 biased intocontact with the ratchet 181 by a spring 185, and a ratchet/pawl cage183. The ratchet 181 is rotatably mounted within the ratchet pawl cage183 and the pawl 182 is coupled to the ratchet/pawl cage 183 and isengageable with the ratchet 181.

[0052] The ratchet 181 is disposed on a distal-most portion of theworm-gear coupling 173. The distal end of the worm gear coupling 173includes a flat surface thereon and the ratchet 181 is positioned on adistal end of the worm gear coupling 173. The flat surface assists incoupling the ratchet 181 to the worm gear coupling 173 such that theratchet 181 will rotate in the first direction 164 with the worm gearcoupling 173 to drive the flexible drive shaft 163. Alternatively,ratchet 181 may be disposed on a rigid drive shaft, a distal end ofwhich would be coupled to the flexible drive shaft 163.

[0053] The ratchet 181 includes teeth 184 for around a portion of anouter surface thereof. As the ratchet 181 is rotated in the firstdirection 164 through the full firing range of the resectioning assembly160, the pawl 182 is sequentially moved into engagement with each of theteeth 184 under the previously mentioned bias and is slid along thesurface of the teeth against the bias to the next tooth 184. As is knownin the art, each of the teeth 184 includes a gradual extension away froma surface thereof on a first side and a substantially radial abuttingsurface on an opposite side thereof to allow the pawl to slide along thesurface of the ratchet 181 in the first direction while preventingrotation of the ratchet 181 in the second direction. Those skilled inthe art will understand that rotation through the full firing range ofthe stapling mechanism depends on the characteristics of the staplingmechanism utilized in the full thickness resectioning device and may,for example, correspond to an arc of rotation of the resectionactivating mechanism 161 necessary to completely fire all of the staplesfrom the stapling head into the tissue surrounding the opening to beformed by removal of the tissue to be resected. Thus, the teeth 184 ofthe ratchet 181 may preferably be disposed around a portion of theratchet 181 selected so that, as the ratchet 181 is rotated through thefull firing range, the pawl 182 prevents the ratchet 181 from rotatingin second direction 169.

[0054] The ratchet 181 and the pawl 182 function as a staple-cuttinglockout mechanism preventing users from activating the tissue cuttingmechanism if the staple firing sequence has not been completed, i.e., byfiring less than all of the required staples by rotating the resectionactivating mechanism 161 partially only in the first direction 164 andthen trying to rotate the resection activating mechanism 161 in thesecond direction 169. Such cutting before the tissue to be cut has beencompletely stapled may result in an opening to an exterior of the organwith possibly dire consequences.

[0055] When the staple firing procedure has been completed, i.e., theflexible drive shaft 163 has been completely rotated clockwise throughthe full staple firing range to fire all of the required staples, therotation of the ratchet 181 has brought an end of the ratchet 181 pastthe reach of the pawl 182 so that the bias of the spring 185 rotates thepawl through the now empty space that had been occupied by the ratchet181 so that the ratchet 181 is left free to rotate in the seconddirection without hindrance by the pawl 182. Thus, the ratchet 181 isconfigured so that it remains in contact with the pawl 182 until theproper amount of rotation in the first direction 164 has been completedand then allows the pawl 182 to rotate away from the teeth 184 of theratchet 181. FIG. 11 illustrates the rotation of flexible drive shaft163 in the first and second directions 164 and 169, respectively.

[0056] Furthermore, the controlling device 162 operates to prevent thetorsional energy stored in the flexible drive shaft 163 during thestaple firing operation from causing uncontrolled rotation of the driveshaft 163 in the second direction (and the corresponding uncontrolledtissue cutting that would result) when the staple-cutting lockoutmechanism 180 disengages to permit the reverse rotation in the seconddirection 169. Thus, controlling device 162 provides for a controlled,gradual release of this stored torsional energy to achieve a smooth andregulated cutting action.

[0057] The control handle 101 also includes a locking mechanism 190 thatalternatively locks the gap adjust assembly 140 and the resectioningassembly 160 so that only one of these mechanisms can be activated atany given time. Either gap adjust ring 141 or resection activatingmechanism 161 may be rotated by the user while the other of themechanisms is locked-out against rotation. Thus, the user may eitheradjust the gap or fire the staples and is not able to do both proceduressimultaneously. This serves to prevent user errors which would otherwiseresult in the actuation of the wrong mechanism.

[0058] Those skilled in the art will understand that the lockingassembly 190 may have a variety of different configurations so long asthis alternative locking function is achieved. According to theembodiment shown in FIGS. 1 and 6, the locking assembly 190 includes aspring loaded pin arrangement 191 having a shuttle 192 and a button beam193. The shuttle 192 which is slidably disposed within the transitionpiece 153 includes a first tab 194 and a second tab 195 which may bothbe extended beyond the transition piece 153 so that they are receivedbetween either the cog teeth 143 of the gap adjust ring 141 or the cogteeth 167 of the resection activating mechanism 161. A top portion ofthe shuttle 192 is disposed within the button beam 193 which is slidablymoves the shuttle 192 within the transition piece 153 between engagementwith the gap adjust ring 141 and the resection activating mechanism 161.The size of the shuttle 192 is selected so that at no time can theshuttle 192 be out of engagement with both the gap adjust ring 141 andthe resection activating mechanism 161.

[0059] As discussed above, the shuttle 192 is slidably disposed withinthe transition piece 153. In order to lock the gap adjust ring 141against further rotation, the user moves the button beam 193 proximallyso that the shuttle 192 is also moved proximally. When the shuttle 192is in the proximal position, the second tab 195 is received between thecog teeth 143 of the gap adjust ring 141 preventing rotation of the gapadjust ring 141 in either the clockwise or the counterclockwisedirection. Additionally, when the tab 195 is received between the cogteeth 143, the tab 194 is removed from the cog teeth 167 so that theresection activating mechanism 161 may be rotated by the user. By movingthe button beam 193 distally, a user may lock the resection activatingmechanism 161 against rotation. As the button beam 193 is moveddistally, the shuttle 192 is moved distally so that the first tab 194 ofthe shuttle 192 is received between the cog teeth 167 of the resectionactivating mechanism 161 preventing rotation thereof. When tab 194 isreceived between the cog teeth 167, the tab 195 is removed from betweenthe cog teeth 143 so that the gap adjust ring 141 may be rotated by theuser.

[0060] As can be seen in FIG. 6, a biasing spring 196 is included withinthe shuttle 192 which biases both the first tab 194 and the second tab195 radially outward from the shuttle 192. This ensures that, when thefirst tab 194 is moved distally toward the resection activatingmechanism 161, the first tab 194 is urged radially outward to secure thefirst tab 194 between the cog teeth 167. Similarly, when the second tab195 is moved proximally toward the gap adjust ring 141, the biasingspring 196 urges the second tab 195 radially outward to secure thesecond tab 195 between the cog teeth 143.

[0061]FIGS. 14 through 16 illustrate second embodiment of the presentinvention including an alternative controlling device 262 including abrake shoe assembly 265 which controls the release rate of torsionalenergy stored in a flexible drive shaft 263 during rotation in a firstdirection (e.g., during stapling). The brake shoe assembly 265 engagesthe flexible drive shaft 263 and functions with a staple-cut knob 261 ina first branch of a Y-shaped control handle 201. Alternatively,controlling device 262 may be configured to function inside a controlhandle 201 with a concentric staple-cut ring and gap adjust ring design,as described in regard to the first embodiment. A gap adjust ring 241acts on a drive shaft 251 in the second branch of the control handle201, through which an endoscope 202 may also be inserted.

[0062] As illustrated in more detail in FIGS. 15 and 16, the brake shoeassembly 265 includes a clutch 267, a stapling casing 270, aspring-loaded brake pad 271, and a hub 268 which may be formed as a discsurrounding and engaging the clutch 267. A rigid drive shaft 266 couplesthe staple firing ring 261 to the flexible drive shaft 263. A proximalend of the rigid drive shaft 266 is screwed into the staple firing ring261 and a proximal end of the flexible drive shaft 263 is coupled to adistal end of the rigid drive shaft 266 (e.g., by being plugged into amating opening in the distal end of the rigid drive shaft 266). Theclutch 267 acts as a directional control mechanism, engaging andsurrounding a portion of the rigid drive shaft 266 to permit rotationthereof inside the clutch 267 only in a first direction 264. Thus, therigid drive shaft 266 and the flexible drive shaft 263 may rotatetogether freely inside the clutch 267 only in the first direction 264 toaccomplish a first operative procedure, e.g., tissue stapling. Asdescribed above in regard to the first embodiment, rotation of theflexible drive shaft 263 in the first direction 264 may drive a staplingmechanism at the distal end of the device (not shown) to fire staplesfrom the stapling head into the tissue. The clutch 267 is coupled to theother elements of the brake shoe assembly 265 as described below toprevents a user from beginning a second operative procedure, tissuecutting, before completing the first operative procedure, by preventingfree rotation of the rigid drive shaft 266 and the flexible drive shaft263 in a second direction 269 while the clutch 267 is engaged.

[0063] During the first operative procedure, rotation of flexible driveshaft 263 in the first direction 264 through the staple firing rangeresults in a build up of torsional energy in the flexible drive shaft263. As described above, the release of this torsional energy stored inthe flexible drive shaft 263 is controlled during a second operativeprocedure (e.g., tissue cutting) by the engagement of the rigid driveshaft 266 and the clutch 267 in conjunction with the other components inthe brake shoe assembly 265.

[0064] Flexible drive shaft 263, rigid drive shaft 266, clutch 267, anddisk 268 all are moveably mounted within a stapling casing 270 so thatthey may rotate therein. A brake pad 271 is mounted on a portion of aninner surface of the stapling casing 270 with springs 272 biasing thebrake pad 271 toward the disk 268. This causes the brake pad 271 toengage a pawl ring portion 273 of an outer edge of the disk 268 toprovide frictional resistance to the movement of disk 268 as the pawlring portion 273 comes into contact with the brake pad 271.

[0065] As described above, once the user has fully completed the firstoperative procedure, in order to begin the second operative procedure(e.g., tissue cutting), the user begins rotating the staple firing ring261 in the second direction 269 to rotate the rigid drive shaft 266 andthe flexible drive shaft 263 in the second direction 269. As discussedabove, the clutch 267 prevents counterclockwise rotation of the rigiddrive shaft 266 and the flexible drive shaft 263 therewithin. Thus,during rotation of the staple firing ring 261 in the second direction269, the rigid drive shaft 266 engages the clutch 267 and the disk 268driving rotation of the entire assemblage of the flexible drive shaft263, the rigid drive shaft 266, the clutch 267 and the disk 268 also insecond direction 269.

[0066] Initially, during rotation of the staple firing ring 261 in thesecond direction 269 to begin the second operative procedure, the pawlring portion 273 is in contact with the brake pad 271, which, with theaid of the springs 272, exerts a resisting frictional force against themotion of the rigid drive shaft 266, the clutch 267, and the disk 268for the length of the pawl ring portion 273 (otherwise known as thedwell period for the pawl ring portion 273). In order to rotate therigid drive shaft 266 and the flexible drive shaft 263 in the seconddirection 269 to begin a cutting procedure, the user must apply enoughforce to overcome the frictional resistance exerted by brake pad 271 ondisk 268. This frictional resistance also resists rotation in the seconddirection 269 through release of the torsional energy stored in theflexible drive shaft 263 during the first operative procedure.

[0067] As will be understood by those of skill in the art, the length ofthe pawl ring portion 273 may be determined as a function of an amountof torsional energy stored in the flexible drive shaft 263 during staplefiring procedures, so that the torsional energy stored therein iscompletely dissipated before the dwell period for the pawl ring portion273 has expired. In this embodiment, rotation of staple firing ring 261will not drive the flexible drive shaft 263 to begin the cuttingprocedure until the torsional energy has been released at a controlledrate while pawl ring portion 273 of disk 268 is in contact with brakepad 271. Once the pawl ring portion 273 is no longer in contact with thebrake pad 271 and all of the stored torsional energy has been released,continued rotation of the staple firing ring 261 in the second direction269 to complete the cutting procedure is driven solely by force appliedby the user to the staple firing ring 261. At this point, the forceapplied by the user drives the rigid drive shaft 266 and the flexibledrive shaft 263 freely to actuate a cutting mechanism (not shown)coupled to a distal end of the flexible drive shaft 263.

[0068] At the end of the cutting procedure, the flexible drive shaft 263will store torsional energy biasing the flexible drive shaft to rotatein the first direction 264. However, this stored torsional energy is notsufficient to actuate a stapling mechanism to begin firing staples in anuncontrolled manner, due to the increased higher level of energyrequired for the stapling operation than is required to drive a cuttingmechanism.

[0069] In a third embodiment of the present invention shown in FIGS. 17through 19, a double clutch assembly 365 operates as anotherconfiguration of a controlling device 362 which controls a release rate,during a second operative procedure, of torsional energy stored in aflexible drive shaft 363 during the driving of the flexible drive shaft363 in a first operative procedure. The double clutch assembly 365, asexplained below, serves not only to control the dissipation of torsionalenergy built up in the flexible drive shaft 363 during rotation in afirst direction but also serves as a type of staple-cutting lockoutmechanism preventing a user from beginning a second operative procedurebefore completing the first operative procedure.

[0070] As shown in FIG. 17, the double clutch assembly 365 functionswith a staple-cut knob 361 and the flexible drive shaft 363 in onebranch of a Y-shaped control handle 301, while a gap adjustment knobacts on a drive shaft 351 in the other branch of the control handle 301.As shown in FIGS. 18 and 19, the double clutch assembly 365 includes tworotational assemblies, 370, 380, an assembly housing 390, a decouplingcam 391, a stop cam 392, and a washer 395. The decoupling cam 391 andthe stop cam 392 are attached to the assembly housing 390 and act uponrotational assemblies 370, 380 as explained further below. The washer395 surrounds rigid drive shaft 366 at a distal side of the assemblyhousing 390 and rotates with the rigid drive shaft 366 rubbing againstan interior surface of the assembly housing 390 to control a rate ofrotation of the rigid drive shaft 366, as further explained below.

[0071] The rotational assembly 370 includes a lockhousing 371, a rollerclutch 372, a pawl ring 373, a set screw 377, a ball bearing 378, and aplunge spring 379. The set screw 377 secures the lockhousing 371 to therigid drive shaft 366 so that the lockhousing 371 rotates with the rigiddrive shaft 366. The rigid drive shaft 366 is not attached to thestaple-cut knob 361. However, rotation of the rigid drive shaft 366 isindirectly driven by rotation of the staple-cut knob 361 throughinteraction of the components in the double clutch assembly 365 asexplained further below. The roller clutch 372, resting inside the pawlring 373, engages and surrounds the rigid drive shaft 366 to permitrotation thereof inside the clutch 372 only in a first direction 364,for example clockwise, during a tissue stapling procedure.

[0072] The rotational assembly 380 includes a lockplate 381 and a rollerclutch 382. The lockplate 381 is coupled to the staple-cut knob 361 sothat the lockplate 381 rotates with the staple-cut knob 361. The rollerclutch 382 rests inside the lockplate 381, engaging and surrounding afirst portion of the rigid drive shaft 366 and only permits the rigiddrive shaft 366 to rotate inside the clutch 382 in a second direction369 opposite to the first direction 364. In this example, if clutch 372permits rigid drive shaft 366 to rotate freely in first direction 364,then clutch 382 permits rigid drive shaft 366 to rotate freely in seconddirection 369.

[0073] In the rotational assembly 370, the lockhousing 371 includes acoupling pin 374, a spring 375 and a decoupling pin 376. The couplingpin 374 is biased outward by a spring 375 to engage a notch 383 in thelock plate 381 to couple the lockhousing 371 to the lockplate 381.Rotation of the staple-cut knob 361 in the first direction 364 drivesrotation of the lockplate 381 and the lockhousing 371 in the firstdirection 364 which, in turn, drives rotation of the rigid drive shaft366 and the flexible drive shaft 363 inside the clutch 372 also in thefirst direction 364 to drive a stapling mechanism, as described above.When this rotation is occurring, the pawl ring 373 and the clutch 372 donot rotate relative to the assembly housing 390 as a flat surface of thepawl ring 373 engages ball bearing 378 mounted in assembly housing 390.The ball bearing 378 prevents the pawl ring 373 and the clutch 372 fromrotating inside the assembly housing 390. The ball bearing 378 is biasedagainst the pawl ring 373 by a plunge spring 379. Upon further rotationof the lockhousing 371 to a point at which a stapling operation has beencompleted, the decoupling pin 376 comes into contact with the ballbearing 378 and moves the ball bearing 378 further into assembly housing390 against bias of plunge spring 379 out of position. This then allowsthe pawl ring 373 and the clutch 372 to rotate relative to the assemblyhousing 390.

[0074] As long as the pawl ring 373 and the clutch 372 are coupled tothe assembly housing 390 and the lockhousing 371 is coupled to thelockplate 381, the clutch 372 prevents a user from rotating thestaple-cut knob 361 in the second direction 369 to drive rotation of therigid drive shaft 366 and the flexible drive shaft 363 in the seconddirection 369. As explained further below, the pawl ring 373 and theclutch 372 are not decoupled from the assembly housing 390 and thelockhousing 371 cannot be decoupled from lockplate 381 until the userhas rotated the staple-cut knob in the first direction 364 sufficientlyto complete a tissue stapling procedure. Thus, the two couplings and therestricted one-way rotation permitted inside the clutch 372, togetherfunction as a safety staple-cutting lockout mechanism preventing a userfrom beginning a second operative procedure, until the user hascompleted rotation of the staple-cut knob 361 and the flexible driveshaft 363 in first direction 364 to complete the first operativeprocedure.

[0075] When the user has reached the end of the tissue staplingprocedure, further rotation of the staple-cut knob 361 in the firstdirection 364 along with the lockhousing 371 and the lockplate 381,first brings the decoupling pin 376 into contact with the ball bearing378, thereby decoupling the pawl ring 373 and the clutch 372 from theassembly housing 390. After the ball bearing 378 has moved out ofposition, the pawl ring 373 and the clutch 372 may rotate freely ineither direction 364 or 369, along with the rigid drive shaft 366 andthe flexible drive shaft 363.

[0076] After the pawl ring 373 and the clutch 372 have been decoupledfrom the assembly housing 390, further rotation of the staple-cut knob361 in the first direction 364 decouples the lockhousing 371 from thelockplate 381. This rotation of the staple-cut knob 361 in the firstdirection 364 brings the coupling pin 374 on the lockhousing 371 intocontact with the decoupling cam 391. The decoupling cam 391 depressesthe coupling pin 374 inward against the biased spring 375 as thelockhousing 371 is rotated in the first direction 364 through rotationof the staple-cut knob 361 and the lockplate 381 in the first direction364. Once the coupling pin 374 has been sufficiently depressed inward todisengage from the notch 383, the lockhousing 371 is decoupled from thelockplate 381, and rotation of the staple-cut knob 361 and the lockplate381 in the first direction 364 no longer drives rotation of thelockhousing 371, the rigid drive shaft 366 and the flexible drive shaft363.

[0077] Once both decouplings have occurred, further rotation of thestaple-cut knob in the first direction 364 does not drive furtherrotation of the lockhousing 371 and the rigid drive shaft 366 and theflexible drive shaft 363. The flexible drive shaft 363 releasestorsional energy stored during rotation in the first direction 364during the tissue stapling procedure, by unwinding in the seconddirection 369, thereby rotating the rigid drive shaft 366 along withlockhousing 371, the clutch 372 and the pawl ring 373 in the seconddirection 369 inside the clutch 382. Since the clutch 382 permits therigid drive shaft 366 to rotate freely inside the clutch 382, rotationof the rigid drive shaft 366 in the second direction 369 does not engagethe clutch 382, the lockplate 381 or the staple-cut knob 361.

[0078] The washer 395 surrounding the rigid drive shaft at a distal sideof the assembly housing 390 and rotating with the rigid drive shaft 366,rubs against the assembly housing 390 to slow the rotation rate of therigid drive shaft 366. Friction created by the washer 395 between therigid drive shaft 366 and the assembly housing 390 prevents the flexibledrive shaft 363 from rotating in the second direction 369 during thecourse of its unwinding. Thus, both decouplings and the washer 395together function as part of the controlling device 362 to control adissipation of the stored torsional energy.

[0079] After both decouplings have occurred, further rotation of thestaple-cut knob 361 (no longer driving rotation of the lockhousing 371,the rigid drive shaft 366 and the flexible drive shaft 363) in the firstdirection 364 brings the stop pin 388 on the lockplate 381 into contactwith the stop cam 392 inside the assembly housing 390 and prevents thestaple-cut knob 361 and the lockplate 381 from rotating further in thefirst direction 364. Those skilled in the art will understand that thepositions of the coupling pin 374 and the decoupling pin 376 on thelockhousing 371 and the position of the stop pin 388 on the lockplate381 are selected so that, after the rotating the staple-cut knob 361 inthe first direction 364 through an arc long enough to completely firethe complete range of staples from the stapling head in the distal endof the full thickness resection device into the tissue, the user isprevented from further rotating the staple-cut knob in the firstdirection. Thus, when the staple-cut knob 361 can no longer be rotatedin the first direction 364, the user knows that the device has completedthe tissue stapling procedure and the user may begin the tissue cuttingprocedure by rotating staple-cut knob 361 in the second direction 369 todrive rotation of the flexible drive shaft 363 and actuate a cuttingmechanism.

[0080] Rotation of the staple-cut knob 361 in the second direction 369rotates the lockplate 381 and the roller clutch 382 also in the seconddirection 369. Although the roller clutch 382 permits the rigid driveshaft 366 to rotate freely inside the roller clutch 382 in the seconddirection 369, rotation of the roller clutch 382 in the second direction369 engages and drives the rigid drive shaft 366 (along with thelockhousing 371, the pawl ring 373 and the clutch 372) to rotate in thesecond direction 369 inside the assembly housing 390. Rotation of therigid drive shaft 366 in the second direction 369 rotates the flexibledrive shaft 363 in the second direction 369. Thus, a user rotating thestaple-cut knob 361 in the second direction 369 rotates the lockplate381, the roller clutch 382, the rigid shaft 366 and the flexible driveshaft 363 to engage the cutting mechanism.

[0081] A fourth embodiment of the present invention depicted in FIGS. 20and 21 presents an alternative controlling device 462 including atorsion balancing assembly 465 engaging a rigid drive shaft 466 and aflexible drive shaft 463 to control, during a second operativeprocedure, the release rate of torsional energy stored in flexible driveshaft 463 during a first operative procedure. The torsion balancingassembly 465, as explained below, serves not only to control thedissipation of torsional energy stored in the flexible drive shaft 463but also acts as a staple-cutting lockout mechanism, to prevent a userfrom beginning a second operative procedure before completing a firstoperative procedure.

[0082] As described in regard to the previous embodiments, the torsionbalancing assembly 465 may function either with a staple-cut knob 461mounted in either a Y-shaped control handle or in a control handle withconcentric staple-cut and gap adjust rings. Furthermore, those skilledin the art will understand that a wide variety of control handle shapesand configurations may be employed with the apparatus according to thepresent invention. In the illustrations of this fourth embodiment inFIGS. 20 and 21, rotation of a flexible drive shaft 463 in a firstdirection 464 engages a stapling mechanism at a distal end of a fullthickness resection device. As shown in FIG. 20, the first and seconddirections 464, 469, respectively, in this embodiment are opposite thefirst and second directions employed in the previous embodiments. Rigiddrive shaft 466 runs through the entire torsion balancing assembly 465and is screwed into a staple-cut knob 461 at a proximal end of the rigiddrive shaft 466. A proximal end of the flexible drive shaft 463 iscoupled to a distal end of the rigid drive shaft 466.

[0083] The torsion balancing assembly 465 includes a spring 470, aratchet assembly 480, a housing 490, a bolt 491, a bellville washer 493and a nut 495. The nut 495 is secured to the housing 490 and does notrotate relative to the staple-cut knob 461. The bolt 491 is screwed intothe nut 495, with the bellville washer 493 between the bolt 491 and thenut 495.

[0084] During initial assembly of the torsion balancing assembly 465,when the bolt 491 is screwed into the nut 495, sufficient torque is usedso that, once assembled, the bolt 491, the bellville washer 493 and thenut 495 together store a pre-determined amount of torsional energytherein substantially equal to and opposite an amount of torsionalenergy stored in the assembly during rotation of the rigid drive shaft466, the staple-cut knob 461 and the flexible drive shaft 463 in thefirst direction 464 during a stapling operation. The predeterminedamount of torsional energy stored in the assembled bolt 491, bellvillewasher 493 and nut 495 may be substantially equal to or a predeterminedamount less than an amount of torsional energy stored in the flexibledrive shaft 463 during rotation in the first direction 464 in a tissuestapling procedure. As further explained below, the torsional energystored in the assembled bolt 491, bellville washer 493 and nut 495 isoriented opposite the torsional energy stored in the flexible driveshaft 463 during rotation in the first direction 464 in a tissuestapling procedure so that these oppositely oriented torsional energiescancel a portion or all of one another out. Thus, as a user begins torotate the staple-cut knob in the second direction after completing thestapling operation, the torsion balancing assembly 465 has dissipated aportion or all of the torsional energy stored in flexible drive shaft463 during the stapling operation.

[0085] A ratchet assembly 480 includes a ratchet 481, a pawl 485 and aratchet plate 488. The ratchet 481 is attached to the ratchet plate 488,and both are moveably mounted inside the housing 490. A surface 472 onthe rigid drive shaft and a flat portion (not shown) of an insidesurface 487 of the rachet 481 couples the ratchet 481 to the drive shaft466, so that the ratchet 481 and the ratchet plate 488 rotate with therigid drive shaft 466 in either the first or second direction 464, 469,respectively. The ratchet 481 includes teeth 482 around all or a portionthereof. The pawl 485 is coupled to the housing 490 and is engageablewith the teeth 482 on the ratchet 481 to prevent the rigid drive shaft466 and the staple-cut knob 461 rotating in the second direction 469until the stapling operation has been completed.

[0086] As the staple-cut knob is rotated by a user in the firstdirection 464, the rigid drive shaft 466, the flexible drive shaft 463and the ratchet 481 are rotated in the first direction 464 relative tothe bolt 491, washer 493 and nut 495 through the full firing range ofthe stapling device. The pawl 485 engages with the teeth 482 to preventthe ratchet 481, the rigid drive shaft 466 and the flexible drive shaft463 from rotating in the second direction 469 even if the user appliesforce in this direction to the staple-cut knob 461. Thus, the ratchet isdesigned so that the teeth 482 thereof extend around an arccorresponding to the full firing range of the stapling mechanism.Throughout this range, the pawl 485 prevents the ratchet 481 fromrotating in the second direction 469. Consequently, the rigid driveshaft 466 and the flexible drive shaft 463 are also prevented fromrotating in the second direction 469 and operating a tissue cuttingmechanism until the stapling operation has been completed. The bolt 491is not coupled to the rigid drive shaft 466 until the rotation of theflexible drive shaft 463 and the rigid drive shaft 466 in firstdirection 464 has been completed.

[0087] Once the staple firing procedure has been completed, the pawl 485is disengaged from the teeth 482 of the ratchet 481 by passing throughthe cutout portion 484 formed on the ratchet 481, catch notch 492 onbolt 491, open notch portion 489 on ratchet plate 488 and spring 470, asexplained further below. Once the pawl 485 has been disengaged, thestaple-cut knob 461, the rigid drive shaft 466 and the flexible driveshaft 463 may rotate in the second direction 469 to commence the tissuecutting procedure.

[0088] At the end of staple firing procedure, rotation in the firstdirection 464 of the staple-cut knob 461 along with the rigid driveshaft 466 and the flexible drive shaft 463 brings the cutout portion 484of the ratchet 481 and the open notch portion 489 of the ratchet plate488 into alignment with the catch notch 492 in the bolt 491 as, at thisstage, the bolt 491 is not yet coupled to or rotating with the rigiddrive shaft 466. The spring 470 which is held in place by edge 471 atthe distal end of the surface 472 of the rigid drive shaft 466, biasesthe ratchet plate 488 and the ratchet 481 toward the bolt 491 to couplethe ratchet 481 to the bolt 491 when the cutout portion 484 becomesaligned with the catch notch 492 (i.e., the cutout portion 484 of theratchet 481 is moved proximally into the catch notch 492 in the bolt491). The pawl 485 which is coupled to the housing 490 and remainsstationary relative to the proximal movement of the ratchet plate 488and the ratchet 481, disengages from the teeth 482 during this coupling.Disengagement occurs because, as the ratchet plate 488 and the ratchet481 move proximally toward the bolt 491, the open notch portion 489 ofthe ratchet plate 488 permits the ratchet plate 488 and the ratchet 481to clear the pawl 485.

[0089] Once the pawl 485 has been disengaged from the ratchet 481, andthe ratchet 481 has been coupled to the bolt 491, the ratchet plate 488,the ratchet 481 and the bolt 491 may all rotate together with the rigiddrive shaft 466 within the housing 490. Further rotation of thestaple-cut knob 461 in the first direction 464 may be prevented, forexample, by a stop pin on ratchet 481 which may be brought into contactwith a stop cam attached to housing 490. Alternatively, as shown in thisembodiment, if the bolt 491 is screwed into the nut 495 during theinitial assembly of the torsion balance assembly 465, the staple-cutknob 461 is blocked from further rotation in the first direction 464once the ratchet 481 has been coupled to the bolt 491. After the bolt491 has been coupled to the ratchet 481, attempts to further rotate thestaple-cut knob 461 in the first direction 464 rotate the coupledratchet 481 and the bolt 491 which simply operates to screw the bolt 491further onto the nut 495. The nut 495 which is secured to the assemblyhousing 490, is stationary relative to the movement of the bolt 491 andprevents any further rotation of bolt 491. Consequently, furtherrotation of the ratchet 481, the rigid drive shaft 466, the flexibledrive shaft 463 and the staple-cut knob 461 in the first direction 464is prevented.

[0090] Those skilled in the art will understand that the positions ofthe cutout portion 484, the notch portion 489, and the catch notch 492should preferably be configured so that, when the point is reached atwhich a user may no longer rotate the staple-cut knob 461 in the firstdirection 464, the flexible drive shaft 463 has rotated in the firstdirection 464 through an arc sufficient to completely fire the completerange of staples. Thus, when staple-cut knob 461 may no longer berotated in the first direction 464, the user knows that the device hascompleted the tissue stapling procedure and the user may begin thetissue cutting procedure by rotating the staple-cut knob 461 in thesecond direction 469.

[0091] Then, when the user rotates the staple-cut knob 461 in the seconddirection 469, the ratchet plate 488, the ratchet 481 and the bolt 491all rotate together in the second direction 469, driven by rotation ofthe rigid drive shaft 466 in the second direction 469. After an initialamount of rotation of the staple-cut knob 461 and the rigid drive shaft466 in the second direction 469 has dissipated any torsional energystored in the flexible drive shaft 463 not canceled by the torsionbalancing assembly 465, further rotation of the staple-cut knob 461, therigid drive shaft 466 and the flexible drive shaft 463 actuate thetissue cutting mechanism under control of the user.

[0092] A user's initial rotation of the staple-cut knob 461 and therigid drive shaft 466 in the second direction 469, rotate the ratchet481 and the bolt 491 in the second direction 469, loosening the bolt 491and the bellville washer 492 from the nut 495 as the nut 495 is fixed tohousing 490. Once the bolt 491 has been loosened, the torsional energystored in the flexible drive shaft 463 is dissipated by acting on thebolt 491 to release the pre-determined amount of torsional energypreviously stored therein.

[0093] The amount of stored pre-determined torsional energy stored inthe assembly of the bolt 491, the washer 493 and the nut 495 toeffectively dissipate the torsional energy stored in the flexible driveshaft 463, as described above, may be adjusted by shaping the bellvillewasher 495 prior to the initial assembly of the torsion balance assembly465 to provide a spring-like force or bias between the bolt 491 and thenut 495. In this embodiment, the bellville washer 493, does not restflat on the surface of either the bolt 491 or the nut 495, but is warpedor bent in a middle portion 496 thereof, although those skilled in theart will understand that any variety of shapes of bellville washers 493may be employed to create the desired spring-like force between the bolt491 and the nut 495 when assembled. The warped or bent shape of thebellville washer 493 gives the washer 493 a spring constant anddeflection range engineered to dissipate the desired amount of torsionalenergy.

[0094] The amount of torsional energy stored in the assembly of the bolt491, the washer 493 and the nut 495 may be pre-determined to be equal orsubstantially equal to the sum of the amount of torsional energy exertedby a user in the initial rotation of staple-cut knob in second direction(clockwise) to loosen bolt 491 and washer 493 from nut 495 in additionto an amount of torsional energy stored in the flexible drive shaft 463during the stapling operation. For example, if it is estimated that theflexible drive shaft 463 stores 10 in.lb. of torque during the staplingoperation, and that it takes 2 in. lb. of torque to loosen the bolt 491from the nut 495 to begin rotation of the staple-cut knob 461 in thesecond direction 469, the amount of torque stored in the assembly of thebolt 491, the washer 493 and the nut 495 may preferably be adjusted tobe at least 12 in. lb, if it is desired to have the entire 10 in. lb. oftorque in the flexible drive shaft 463 dissipated at the start of therotation of the staple-cut knob 461 in the second direction 469.

[0095] Once this torsional energy has been dissipated, further rotationby the user of the staple-cut knob 461, the rigid drive shaft 466 andthe flexible drive shaft 463 in the second direction, unscrews orunwinds the bolt 491 from the nut 495 and the flexible drive shaft 463engages the tissue cutting mechanism to begin the tissue cuttingprocedure.

[0096] As discussed above, there are a variety of configurations oflocking mechanisms 190 available to alternatively the lock gap adjustassembly 140 and the resectioning assembly 160 against further rotation,so that, at any given time, a user may activate only one of theseassemblies and perform only one of these procedures at any particulartime.

[0097] In a fifth embodiment of the present invention shown in FIGS. 22through 24, a locking assembly 590 includes a lockout beam arrangement591. The lockout beam arrangement 591 includes a lockout beam 592 and aswitch beam 595. The lockout beam 592, which may, for example be formedas a cantilevered beam, is slidably disposed within a transition piece553. A top portion of the lockout beam 592 is disposed within the switchbeam 595 which may be utilized to slidably move the lockout beam 592within the transition piece 553 so that the lockout beam 595 engages oneof a gap adjust ring 541 and a staple firing ring 561. The lockout beam592 includes a gap adjust lockout pawl 593 and a staple lockout pawl594. The length of the gap adjust lockout pawl 593 is selected so thatit may be extended beyond the transition piece 553 to be receivedbetween cog teeth 543 of the gap adjust ring 541. Similarly, the lengthof the staple lockout pawl 593 is selected so that it may be extendedbeyond the transition piece 553 to be received between cog teeth 567 ofthe staple firing ring 561.

[0098] In order to render the staple firing ring operational, a usermust first lock the gap adjust ring 541 against further rotation bymoving the switch beam 595 proximally, thereby moving the lockout beam592 proximally as well. When in this proximal position with the gapadjust lockout pawl 593 received between the cog teeth 543, the lockoutbeam 592 prevents further rotation of the gap adjust ring 541 in eitherdirection. When the gap adjust lockout pawl 593 is received between thecog teeth 543, the staple lockout pawl 594 is not received between thecog teeth 567, so that the staple firing ring 561 may be rotated ineither direction. In order to render the gap adjust ring 541 operable, auser must first lock the staple firing ring 561 against further rotationby moving the switch beam 595 distally which, in turn, moves the lockoutbeam 592 distally. When the lockout beam 592 is in this position, thestaple firing ring 561 is locked from further rotation in any directionas the staple lockout pawl 594 of the lockout beam 592 is receivedbetween cog teeth 567 in the staple firing ring 561 thereby preventingthe staple firing ring 561 from further rotation in either direction.

[0099] As may be seen in FIGS. 23 and 24, both the gap adjust lockoutpawl 593 and the staple lockout pawl 594 may be formed as cantileveredpawls extending outward from the lockout beam 592. The gap adjustlockout pawl 593 and the staple lockout pawl 594 are mounted so thatthey cam outward away from the lockout beam 592 to ensure securepositioning of the prongs between the cog teeth 543 and 567,respectively.

[0100] The disclosed embodiments are illustrative of the various ways inwhich the present invention may be practiced. Those skilled in the artwill recognize that may variations and alternative embodiments may beimplemented without departing from the spirit and scope of the presentinvention.

What is claimed is:
 1. A control mechanism for a resectioning device,comprising: a first actuator coupled to a flexible drive shaft foractuating a first mechanism when operated in a first direction and foractuating, when operated in a second direction, a second mechanism; anda first lockout mechanism coupled to the first actuator for preventingactuation of the first actuator in the second direction before apredetermined amount of actuation in the first direction has beencompleted.
 2. The control mechanism according to claim 1, furthercomprising a second actuator for actuating a third mechanism, the secondactuator being coupled to the first actuator by a second lockoutmechanism permitting operation of only one of the first and secondactuators at a given time.
 3. The control mechanism according to claim2, wherein the second lockout mechanism includes a locking membermoveable between a first position engaging the first actuator andpreventing actuation thereof and a second position engaging the secondactuator and preventing actuation thereof, wherein, when in the firstposition, the locking member is disengaged from the second actuator and,when in the second position, the locking member is disengaged from thefirst actuator.
 4. The control mechanism according to claim 3, whereinthe first actuator includes a first abutting surface which, when thelocking member is in the first position, engages the locking member andwherein the second actuator includes a second abutting surface which,when the locking member is in the second position, engages the lockingmember.
 5. The control mechanism according to claim 1, furthercomprising a torque controlling mechanism coupled to the flexible driveshaft for controlling a release, after the predetermined amount ofactuation of the first actuator in the first direction has beencompleted, of torsional energy stored in the flexible drive shaft. 6.The control mechanism according to claim 5, wherein the torquecontrolling mechanism includes a braking member which resists rotationof the flexible drive shaft in a direction opposite a direction ofrotation imparted to the flexible drive shaft by actuation of the firstactuator in the first direction.
 7. The control mechanism according toclaim 6, wherein the braking mechanism frictionally engages one of theflexible drive shaft and a member extending between the flexible driveshaft and the first actuator.
 8. The control mechanism according toclaim 5, wherein the torque controlling mechanism includes a gearingmechanism which resists rotation of the flexible drive shaft in adirection opposite a direction of rotation imparted to the flexibledrive shaft by actuation of the first actuator in the first direction.9. The control mechanism according to claim 8, wherein the gearingmechanism includes a gear that engages one of the flexible drive shaftand a member coupled thereto for rotation with the flexible drive shaft.10. The control mechanism according to claim 1, wherein the firstlockout mechanism includes a clutch mechanism that engages one of theflexible drive shaft and a member coupled thereto for rotation with theflexible drive shaft.
 11. The control mechanism according to claim 1,wherein the first actuator and the first lockout mechanism are mountedin a control handle defining a central endoscope receiving channelextending therethrough.
 12. The control mechanism according to claim 11,wherein a distal end of the control handle is coupled to a flexiblesheath through which the flexible drive shaft extends to a resectiondevice.
 13. A control handle for a resectioning device, comprising: aclamping assembly including a clamping ring mounted on a first exteriorsurface of the control handle; and a staple mechanism actuator includinga staple firing ring mounted on a second exterior surface of the body,the staple firing ring being concentric with the clamping ring andwherein the staple firing ring and the clamping ring define a centralendoscope receiving channel extending therethrough.
 14. A controlmechanism for a full thickness resection device, comprising: a firstactuator coupled to a flexible drive shaft; a staple actuating mechanismcoupled to the flexible drive shaft to drive the drive shaft in a firstoperative mode; and a torque controlling device engaging the flexibledrive shaft to control a dissipation of torsional energy stored in theflexible drive shaft during the first operative mode.
 15. The controlmechanism according to claim 14, wherein the controlling device includesa worm gear assembly coupled to the staple actuating mechanism and tothe flexible drive shaft.
 16. The control mechanism according to claim14, wherein the controlling device includes a braking assembly engagingthe flexible drive shaft to retard rotation thereof in the seconddirection.
 17. The control mechanism according to claim 16, wherein thebraking assembly operates during an initial phase of the rotation of theflexible drive shaft in the second direction after completion of thefirst operative mode.
 18. The control mechanism according to claim 14,further comprising a rigid drive shaft coupled between the stapleactuating mechanism and the flexible drive shaft and wherein thecontrolling device is mounted within a casing and includes a doubleclutch assembly having a casing, and first and second rotationalassemblies moveably mounted within the casing, the first rotationalassembly being selectively couplable to the second rotational assembly,to the casing, and to the rigid drive shaft, the second rotationalassembly being coupled to the staple actuating mechanism and beingselectively coupleable to the rigid drive shaft.
 19. The controlmechanism according to claim 14, wherein the controlling device is atorsion balancing assembly, the torsion balancing assembly including amechanism for preloading the flexible drive shaft with a torque oppositein direction to that stored in the flexible drive shaft during the firstoperative mode.
 20. The control mechanism according to claim 19, whereinthe torsion balancing assembly includes: a housing; a nut secured to thehousing; a bolt screwed into the nut; a bellville washer resting betweenthe bolt and the nut; a ratchet assembly engaging the rigid drive shaftand moveably mounted within the housing; and a spring biasing theratchet assembly towards the bolt, a distal end of the spring beingfixedly coupled to the rigid drive shaft.
 21. A resectioning assemblyfor controlling operation of a full thickness resection device,comprising: a flexible drive shaft; a resection actuating mechanismcoupled to the flexible drive shaft, the resection actuating mechanismconfigured to rotate the flexible drive shaft in a first direction; anda controlling device engaging the flexible drive shaft to control, asthe flexible drive shaft rotates in a second direction, a dissipation oftorsional energy stored in the flexible drive shaft during rotation inthe first direction.
 22. The resectioning assembly according to claim21, wherein rotation of the flexible drive shaft in the first directionactuates a tissue stapling mechanism of the full thickness resectiondevice and rotation of the flexible drive shaft in the second directionactuates a tissue cutting mechanism of the full thickness resectiondevice.
 23. The resectioning assembly according to claim 22, whereinoperation of the resection actuating mechanism in a first mode rotatesthe flexible drive shaft in the first direction and operation of theresection actuating mechanism in a second mode rotates the flexibledrive shaft in the second direction.
 24. The resectioning assemblyaccording to claim 21, further comprising a rigid drive shaft couplingthe resection actuating mechanism to the flexible drive shaft.
 25. Theresectioning assembly according to claim 24, wherein the resectionactuating mechanism includes a staple-cut knob, and rotating thestaple-cut knob in the first direction rotates the rigid drive shaft andthe flexible drive shaft in the first direction.
 26. The resectioningassembly according to claim 25, wherein the controlling device includesa brake shoe assembly having: a clutch engaging and surrounding aportion of the rigid drive shaft; a disk engaging and surrounding theclutch, a brake pad; and a casing rigidly coupled to a body of theresectioning assembly, wherein the clutch and the disk are moveablymounted within the casing and the brake pad is mounted within the casingand configured to act on the disk during rotation of the flexible driveshaft in the second direction.
 27. The resectioning assembly accordingto claim 26, wherein the clutch prevents rotation of the rigid driveshaft in the second direction.
 28. The resectioning assembly accordingto claim 27, wherein the rigid drive shaft rotates inside the clutch inthe first direction.
 29. The resectioning assembly according to claim28, wherein rotation of the staple-cut knob in the second directionrotates the rigid drive shaft in the second direction, and rotation ofthe rigid drive shaft in the second direction engages and rotates theclutch and the disk in the second direction.
 30. The resectioningassembly according to claim 29, wherein the disk includes a pawl ringconfigured to contact the brake pad for during rotation in the seconddirection of the disk, the clutch, the rigid drive shaft and theflexible drive shaft.
 31. The resectioning assembly according to claim30, wherein the brake pad is mounted within the casing with at least onespring biasing the brake pad towards the pawl ring portion on the disk.32. The resectioning assembly according to claim 31, wherein the pawlring portion is oriented on the disk to contact the brake pad at abeginning of the rotation of the disk, the clutch, the rigid drive shaftand the flexible drive shaft in the second direction.
 33. Theresectioning assembly according to claim 32, wherein at least one of alength and a duration of the contact on the brake pad by the pawl ringportion is determined as a function of an amount of torsional energystored in the flexible drive shaft during the rotation of the flexibledrive shaft in the first direction.
 34. The resectioning assemblyaccording to claim 32, wherein the pawl ring portion has a dwell periodof a sufficient length to dissipate an amount of torsional energy storedin the flexible drive shaft, the dissipation occurring at a beginning ofthe rotation in the second direction of the disk, the clutch, the rigiddrive shaft and the flexible drive shaft.
 35. The resectioning assemblyaccording to claim 34, wherein, after the dwell period has expired, thedisk, the clutch, the rigid drive and the flexible drive shaft rotateinside the casing in the second direction substantially free ofresistance from the brake pad.
 36. The resectioning assembly accordingto claim 34, wherein, the dwell period has expired, a tissue cuttingmechanism coupled to a distal portion of the flexible drive shaft isactivated by rotation of the staple-cut knob in the second direction.37. The resectioning assembly according to claim 36, wherein thecontrolling device includes a double clutch assembly having a casing,and first and second rotational assemblies moveably mounted within thecasing, the first rotational assembly being selectively coupleable tothe second rotational assembly, to the casing, and to the rigid driveshaft, the second rotational assembly being coupled to the staple-cutknob and being selectively coupleable to the rigid drive shaft.
 38. Theresectioning assembly according to claim 37, wherein the firstrotational assembly is decoupled from the casing and the secondrotational assembly when the first operative procedure is complete. 39.The resectioning assembly according to claim 38, wherein the secondrotational assembly includes means for coupling the staple-cut knob tothe rigid drive shaft when the staple-cut knob is rotated in the seconddirection.
 40. The resectioning assembly according to claim 37, wherein,when the first rotational assembly is decoupled from the casing and thesecond rotational assembly, torsional energy stored in the flexibledrive shaft is dissipated by an unwinding of the flexible drive shaftand rotation in the second direction of the rigid drive shaft relativeto the second rotational assembly.
 41. The resectioning assemblyaccording to claim 37, wherein the first rotational assembly includes: alockhousing secured to and rotating with the rigid drive shaft; a pawlring; a first-clutch resting inside the pawl ring and surrounding andselectively engaging a first portion of the rigid drive shaft to preventthe rigid drive shaft from rotating inside the first clutch in thesecond direction; and a ball bearing disposed between an outer surfaceof the pawl ring and an inner surface of casing of the resectioningassembly selectively coupling the pawl ring and the first clutch to thecasing.
 42. The resectioning assembly according to claim 41, wherein,when the first rotational assembly is coupled to the second rotationalassembly, to the casing and to the rigid drive shaft, rotation of thestaple-cut knob in the first direction rotates the second rotationalassembly in the first direction and rotates the lockhousing and therigid drive shaft in the first direction inside the first clutch,wherein the first clutch and the pawl ring remain stationary relative tothe rigid drive shaft.
 43. The resectioning assembly according to claim41, wherein the lockhousing includes a decoupling pin decoupling thefirst rotational assembly from the casing when rotation of the rigiddrive shaft and the lockhousing brings the decoupling pin into contactwith the ball bearing to move the ball bearing out of a couplingposition.
 44. The resectioning assembly according to claim 43, whereinthe casing includes a decoupling cam decoupling the first rotationalassembly from the second rotational assembly by moving the coupling pinout of a coupling position when rotation of the first rotationalassembly in the first direction brings the coupling pin into contactwith the decoupling cam.